E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane

This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Overview

• Status: Completed
• Conditions: Stage IIIB Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: eribulin mesylate

Detailed Description

OBJECTIVES:

I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.

II. Evaluate the time to progression and overall survival of patients treated with this drug.

III. Evaluate the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Stage IIIB or IV disease
• Recurrent or progressive disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Must have received prior treatment with platinum-based therapy and a taxane
• Asymptomatic brain metastasis allowed provided off steroids for > 2 weeks
• Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%
• Life expectancy > 3 months
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 2.0 mg/dL
• AST/ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No neuropathy ≥ grade 2

• No uncontrolled illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would preclude study compliance
• No other concurrent investigational agents
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered
• No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant setting
• No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion Criteria:

• Absolute neutrophil count ≥ 1,500/mm³
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: eribulin mesylate; Given IV; Other Names: E7389; ER-086526; B1939; halichrondrin B analog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (CR or PR) According to RECIST Criteria	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR	Tumor measurements repeated every 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Will be estimated using the product-limit method of Kaplan and Meier.	From start of treatment to death from any cause, assessed up to 5 years
Progression Free Survival	Will be estimated using the product-limit method of Kaplan and Meier.	From start of treatment to the time of documented progression, assessed up to 5 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Barbara Gitlitz, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 16, 2006
• First Submitted That Met QC Criteria: November 16, 2006
• First Posted (Estimate): November 17, 2006

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NCI-2009-01159 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); N01CM62201 (U.S. NIH Grant/Contract); N01CM62204 (U.S. NIH Grant/Contract); N01CM62209 (U.S. NIH Grant/Contract); CDR0000514516; PHII-74 (Other Identifier: City of Hope); 7437 (Other Identifier: CTEP)